[Phase I study of CM-Na combined with concurrent radiochemotherapy for advanced esophageal carcinoma]

Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%. This study aimed to explore maximum tolerance dose (MTD) of sodium glycididazole(CM-Na) in the combined planning as the recommended dose for phase II study.

Twenty-two patients with pathologically confirmed esophageal squamous carcinoma of stage III-IV were recruited according to the inclusion criteria. All patients were divided into 4 groups (at least 3 patients in a group) by turn as the dose of CM-Na escalated from 400 to 600, 700, and 800 mg x (m(2) x d)(-1) by Fibonacci's method, and treated according to the plan. All patients underwent the same concurrent radiochemotherapy. Conventional radiotherapy was performed with total dose of 60 Gy within 6 weeks. CM-Na was given 1 h before radiotherapy at Monday, Wednesday, and Friday every week, combined with 2 circles of continuous 5-day chemotherapy of 500 mg x (m(2) x d)(-1) of 5-fluoruracil (5-FU) and 20 mg x (m(2) x d)(-1) of cisplatin (DDP) at the first and the fifth week.

Low-grade gastrointestinal adverse reactions were observed in the 4 groups during the period of chemotherapy, but no adverse reactions of nervous system, kidney, or heart were observed. Severe adverse reactions occurred in 800 mg x (m(2) x d) (-1) group, included 3 cases of grade III radioactive esophagitis, 2 cases of grade IV aminopherase risen, and 1 case of grade III thrombocytopenia. All the 19 patients in the rest 3 groups suffered grade I-II thrombocytopenia. The rates of complete remission and partial remission were 27% (6/22) and 68% (15/22) at the end of treating, and 46% (10/22) and 54% (12/22) 1 month after treating.

Liver disfunction is the main dose-limited toxicity of the treatment schemeu 700 mg x (m(2) x d) (-1) of CM-Na is recommended to phase II clinical study.